US-20230285702-A1 - POSITIVE PRESSURE VENTILATION APPARATUS AND POSITIVE PRESSURE MASK

US20230285702A1US 20230285702 A1US20230285702 A1US 20230285702A1US-20230285702-A1

Abstract

A positive pressure ventilation apparatus may include a positive pressure mask; a positive pressure source; and an exhalation filter. The positive pressure mask may include a mask body having a patient-contact perimeter and including a flexible concertinaed portion of uniform flexion continuously around the mask body. The flexible concertinaed portion may include a plurality of ridges. The positive pressure mask may further include a gas inlet to the mask body configured to be connected to the positive-pressure source; and an adhesive seal positioned at the patient-contact perimeter which may be positioned at the outermost portion of the patient contact perimeter. The adhesive seal may comprise one or more lavers. Each layer may include one or more cover members, each of which may include at least one removable tab; and at least one perforation. Each layer may further include a dual-sided form carrier with adhesive material on one or both sides.

Inventors

QUINONES ALPHONSO

Assignees

QUINONES ALPHONSO

Dates

Publication Date: 20230914
Application Date: 20230515
Priority Date: 20200402

Claims (20)

1 . A positive pressure ventilation apparatus, comprising: a positive pressure mask; a positive-pressure source coupled to the positive pressure mask; an exhalation filter and positive pressure mask, the positive pressure mask comprising: a mask body configured to cover user's mouth and nostrils, the mask body having a user-contact perimeter, the mask body comprising a flexible concertinaed portion of uniform flexion continuously around the mask body, the flexible concertinaed portion comprising a plurality of ridges, at or adjacent to the user-contact perimeter to accommodate 360 degree movement of a user's face during use, the plurality of ridges configured to be stacked perpendicular to the user's face, such that the plurality of ridges are configured to move away from and toward the user's face; a gas inlet to the mask body configured to be connected to the positive-pressure source; and two or more layers of adhesive seal positioned at the user-contact perimeter to secure the mask body to the user's face and prevent leakage of the concertinaed portion, the adhesive seal being positioned at an outermost portion of a user contact perimeter, and the adhesive seal further comprising one or more removable layers.
2 . The positive pressure ventilation apparatus as claimed in claim 1 , wherein the user-contact perimeter comprises a cushioned portion.
3 . The positive pressure ventilation apparatus as claimed in claim 2 , wherein the cushioned portion comprises a gel cushion.
4 . The positive pressure ventilation apparatus as claimed in claim 1 , wherein the mask body is at least in part light-transmissible.
5 . The positive pressure ventilation apparatus as claimed in claim 1 , wherein the adhesive seal is modular and interchangeable.
6 . The positive pressure ventilation apparatus as claimed in claim 1 , further comprising a strap for engaging with a user's head to hold the positive pressure mask in position.
7 . The positive pressure ventilation apparatus as claimed in claim 1 , wherein the gas inlet comprises a swivel assembly.
8 . The positive pressure ventilation apparatus as claimed in claim 1 , wherein there is a uniform distance between the flexible concertinaed portion and the user-contact perimeter around at least a majority of the mask body.
9 . A positive pressure mask, comprising: a mask body configured to cover a user's mouth and nostrils, the mask body having a user-contact perimeter, the mask body comprising a uniform flexion around the mask body, a flexible concertinaed portion comprising a plurality of ridges, at or adjacent to the user-contact perimeter to accommodate 360 degree movement of a user's face during use, the plurality of ridges configured to be stacked perpendicular to the user's face, such that the plurality of ridges are configured to move away from and toward the user's face; a gas inlet to the mask body configured to be connected to a positive-pressure source; and two or more layers of adhesive seal positioned at the user-contact perimeter to secure the mask body to the user's face, the adhesive being positioned at an outermost portion of a user contact perimeter, the adhesive seal further comprising one or more layers, each layer comprising: one or more cover members, the cover members each comprising: at least one removable tab; and at least one perforation; and a dual-sided form carrier with adhesive material on one or both sides.
10 . The positive pressure mask as claimed in claim 9 , wherein the user-contact perimeter comprises a cushioned portion.
11 . The positive pressure mask as claimed in claim 9 , further including a cushioned portion comprising a gel cushion.
12 . The positive pressure mask as claimed in claim 9 , wherein the adhesive seal is modular and interchangeable.
13 . The positive pressure mask as claimed in claim 9 , wherein the gas inlet comprises a swivel assembly.
14 . The positive pressure mask as claimed in claim 9 , wherein the mask body is formed from a flexible plastics material.
15 . The positive pressure mask as claimed in claim 9 , wherein there is a uniform distance between the flexible concertinaed portion and the user-contact perimeter around at least a majority of the mask body.
16 . A positive pressure ventilation apparatus, comprising: a positive pressure mask; and an adhesive strip, comprising: an acrylate or a synthetic rubber attached to either side of a gel cushion; the adhesive strip comprising one or more layers of the adhesive strip; wherein the adhesive strip comprises: two or more layers of an adhesive seal positioned at a user-contact perimeter to secure the positive pressure mask to a user's face, the adhesive being positioned at an outermost portion of a user contact perimeter, the adhesive seal further comprising one or more layers, each layer comprising: one or more cover members, the cover members each comprising: at least one removable tab; and at least one perforation; and a dual-sided form carrier with adhesive material on one or both sides.
17 . The positive pressure ventilation apparatus as claimed in claim 16 , wherein the adhesive strip comprises of one or more layers.
18 . The positive pressure ventilation apparatus as claimed in claim 16 , wherein the adhesive strips may be attached to a non-invasive ventilation apparatus.
19 . The positive pressure ventilation apparatus as claimed in claim 16 , wherein the adhesive strip is prepackaged or provided separately to prolong mask use by the user.
20 . The positive pressure ventilation apparatus as claimed in claim 16 , wherein the adhesive strip is double-sided, and user may remove a top layer to reveal the cover member of a subsequent layer of the adhesive strip.

Description

FIELD OF THE TECHNOLOGY The present disclosure relates generally to apparatuses for non-invasive ventilation of a patient requiring ventilatory care, and more specifically to an enhanced positive pressure mask which is configured to provide non-invasive ventilation without gas leak from the positive pressure mask when the patient moves their head. In particular, this disclosure relates to a positive pressure mask which can be adhered to the patient's face, as well as having a soft or flexible concertinaed portion which accommodates movement of the patient's head without introducing gas leaks. INTRODUCTION Medical professionals caring for patients with respiratory infections, particularly for highly infectious diseases such as the novel coronavirus disease 2019 (COVID-19), are at high risk of contracting the infection. Aerosol-generating procedures, such as non-invasive ventilation, are of particularly high risk due to mask leaks, typically from around the edge of the mask where the mask meets the face. Non-invasive ventilation units with an exhalation filter could be used to support acute pulmonary infectious disease patients with respiratory failure. However, the high incidence of mask leakage may result in incomplete filtration, as per Antonio M. Esquinas, S. Egbert Pravinkumar. Noninvasive mechanical ventilation in high-risk pulmonary infections: a clinical review on behalf of the International NIV Network European Respiratory Review 2014 23: 427-438. This was demonstrated during the Severe Acute Respiratory Syndrome (SARS) pandemic of November 2002, in which non-invasive ventilation created aerosol generation to allow airborne transmission of the virus. There are many case reports of considerable SARS transmission risk with the use of non-invasive ventilators to many patients over extended distances, as per Li Y, Huang X, Yu IT, Wong TW, Qian H. Role of air distribution in SARS transmission during the largest nosocomial outbreak in Hong Kong. Indoor Air 2005; 15: 83-95. Poorly positioned masks result in leaked gas at the masks, causing aerosol dispersion and increasing the risk to medical professionals. Due to the significant risk of infection to the medical practitioner providing care for a patient with a highly contagious respiratory disease such as COVID-19, mechanical ventilation is the primary mechanism for care, despite the risk to the patient of an invasive intervention. Typically, to prevent cross-infection, practitioners progressively tighten mask straps to reduce the risk of mask leaks. However, if this method is employed for an extended period of time, it significantly increases the incidence of mask-related facial skin breakdown, as per Wellington P. Yamaguti, Eliana V. Moderno, Sandra Y. Yamashita, et al. Treatment-Related risk factors for the development of skin breakdown in subjects with acute respiratory failure undergoing noninvasive ventilation or Continuous Positive Airway Pressure (“CPAP”). Respiratory Care 2014 59(10), 1530. Progressively increasing strap tension to eliminate gas leakage is a primary cause of facial skin pressure ulcers. Jaber S. Alqahtani, Mohammed D. AlAhmari, Evidence based synthesis for prevention of noninvasive ventilation related facial pressure ulcers. Saudi Med J. 39(5), 443-552. The novel application of adhesive at or near the mask perimeter to form a seal will allow practitioners to avoid progressive tightening of mask straps while also improving gas sealing. Furthermore, the use of adhesive instead of, or in addition to, straps is more resistant to patient movements and other displacements which would otherwise result in leakage and aerosol escape from the mask. The application of an interchangeable, modular, multi-layered adhesive seal at the mask perimeter will furthermore allow this single patient use device to be reused on the same patient. SUMMARY An aspect of the present disclosure may include a positive pressure ventilation apparatus. The positive pressure ventilation apparatus may include a positive pressure mask; a positive pressure source coupled to the positive pressure mask; and an exhalation filter positioned on a gas flow path interconnecting the positive-pressure source and positive pressure mask. The positive pressure mask may include a mask body configured to cover a patient's mouth and nostrils. The mask body may have a patient contact perimeter and include a flexible concertinaed portion of uniform flexion continuously around the mask body. The flexible concertinaed portion may include a plurality of ridges. The plurality of ridges may be configured to be stacked perpendicular to the patient's face. The positive pressure mask may further include a gas inlet to the mask body configured to be connected to the positive-pressure source; and an adhesive seal positioned at the patient-contact perimeter. The adhesive seal may be positioned at the outermost portion of the patient contact perimeter. The adhesive seal may further comprise one or